Direct skeletal attachment of prosthetic limbs, commonly known as osseointegration (“OI”), is being investigated by our team with the goal of safely introducing this technology into the United States for human use. OI technology allows for anchorage of prosthetic devices directly to bone using an intramedullary stem. For OI to be effective and secure, bone ingrowth and remodeling around the implant must be achieved. Physicians need an effective way to measure bone remodeling in order to make informed decisions on prescribed loading. This work describes methodology that was developed that utilizes computed tomography (CT) imaging as a tool for analyzing bone remodeling around an osseointegrated implant. A subject implanted with a new Percutaneous Osseointegrated Prosthesis (POP) (DJO Surgical, Austin, TX) had CTs taken of their residual femur at 6-weeks and 12-months post-op in a FDA Early Feasibility Study with Institutional Review Board approval. Three-dimensional models of the femur were created from dicom files of the CT slices using Mimics (v21.0, Materialise, Leuven, Belgium). Each scan was segmented into four objects: cortical bone, medullary cavity, total volume (cortical bone plus the medullary cavity) and endoprosthetic stem ( Following segmentation, models were uploaded to 3-Matic Research (v13.0, Materialise, Leuven, Blegium) in STL format for alignment to a common world coordinate system ( BML and STLs of the aligned medullary cavity and femur volume were entered into custom Matlab code designed to measure cortical and medullary morphology in transverse cross sections of the femur. Morphology data from 6-weeks and 12-month time points were compared in order to determine if bone remodeling around the POP implant could be detected using these methods.Introduction
Method
